What is NDC 76420-768?

76420-768 is the product NDC for Oxycodone hydrochloride, Oxycodone hydrochloride 30 mg/1 tablet, listed with the FDA by Asclemed USA, Inc.. It has 7 package NDCs, shown above in 10- and 11-digit form.

Asclemed USA, Inc., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Oxycodone hydrochloride?

130 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Oxycodone hydrochloride NDC 76420-768 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)76420-768Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76420-0768Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
76420-768-01	76420076801	100 TABLET in 1 BOTTLE (76420-768-01)Marketed from Jun 25, 2024
76420-768-05	76420076805	500 TABLET in 1 BOTTLE (76420-768-05)Marketed from Jun 25, 2024
76420-768-10	76420076810	10 TABLET in 1 BOTTLE (76420-768-10)Marketed from Jun 25, 2024
76420-768-20	76420076820	20 TABLET in 1 BOTTLE (76420-768-20)Marketed from Jun 25, 2024
76420-768-30	76420076830	30 TABLET in 1 BOTTLE (76420-768-30)Marketed from Jun 25, 2024
76420-768-60	76420076860	60 TABLET in 1 BOTTLE (76420-768-60)Marketed from Jun 25, 2024
76420-768-90	76420076890	90 TABLET in 1 BOTTLE (76420-768-90)Marketed from Jun 25, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Oxycodone hydrochloride
Generic name (nonproprietary): oxycodone hydrochloride
Active ingredients: Oxycodone hydrochloride — 30 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Asclemed USA, Inc.NDC labeler code 76420
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202116
Marketing start: Dec 30, 2011
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 76420-768_1bb160c8-a76d-7033-e063-6294a90adbefSPL ID 1bb160c8-a76d-7033-e063-6294a90adbefSPL set ID 1bb147d4-1ab6-dd70-e063-6394a90a67a8RxCUI 1049611, 1049618, 1049621UNII C1ENJ2TE6C
Pharmacologic class: Opioid Agonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N476420076801 followed by a unit qualifier and the quantity

Package 76420-0768-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jun 25, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions ( 5.1 )] , reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): • Have not been tolerated or are not expected to be tolerated, • Have not provided adequate analgesia or are not expected to provide adequate analgesia. Oxycodone hydrochloride tablets should not be …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76420-768

What is NDC 76420-768?: 76420-768 is the product NDC for Oxycodone hydrochloride, Oxycodone hydrochloride 30 mg/1 tablet, listed with the FDA by Asclemed USA, Inc.. It has 7 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Oxycodone hydrochloride.
What is the active ingredient?: Oxycodone hydrochloride.
Who is the labeler?: Asclemed USA, Inc., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Oxycodone hydrochloride?: 130 other product NDCs are listed under this name. See all Oxycodone hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Oxycodone hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Oxycodone Hydrochloride	Oxycodone hydrochloride 15 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-967	60760-0967-3060760-0967-60
Oxycodone Hydrochloride	Oxycodone hydrochloride 10 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-966	60760-0966-3060760-0966-60
Oxycodone Hydrochloride	Oxycodone hydrochloride 5 mg/1	TabletOral	Camber Pharmaceuticals Inc	31722-484	31722-0484-0131722-0484-05
Oxycodone Hydrochloride	Oxycodone hydrochloride 10 mg/1	TabletOral	Camber Pharmaceuticals Inc	31722-485	31722-0485-0131722-0485-05
Oxycodone Hydrochloride	Oxycodone hydrochloride 20 mg/1	TabletOral	Camber Pharmaceuticals Inc	31722-486	31722-0486-0131722-0486-05
Oxycodone Hydrochloride	Oxycodone hydrochloride 5 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-954	60760-0954-3060760-0954-60
Oxycodone Hydrochloride	Oxycodone hydrochloride 15 mg/1	TabletOral	ST. MARY'S MEDICAL PARK PHARMACY	60760-956	60760-0956-3060760-0956-6060760-0956-90
Oxycodone Hydrochloride	Oxycodone hydrochloride 5 mg/1	TabletOral	Strides Pharma Science Limited	64380-259	64380-0259-0164380-0259-02
Oxycodone Hydrochloride	Oxycodone hydrochloride 10 mg/1	TabletOral	Strides Pharma Science Limited	64380-260	64380-0260-01
Oxycodone Hydrochloride	Oxycodone hydrochloride 15 mg/1	TabletOral	Strides Pharma Science Limited	64380-261	64380-0261-0164380-0261-02

All 131 Oxycodone hydrochloride NDCs

Other NDCs under ANDA 202116

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 202116
Product	Strength	Form · route	Labeler	Product NDC
Oxycodone hydrochloride	Oxycodone hydrochloride 5 mg/1	TabletOral	Alvogen, Inc.	47781-263
Oxycodone hydrochloride	Oxycodone hydrochloride 15 mg/1	TabletOral	Alvogen, Inc.	47781-264
Oxycodone hydrochloride	Oxycodone hydrochloride 30 mg/1	TabletOral	Alvogen, Inc.	47781-265
Oxycodone hydrochloride	Oxycodone hydrochloride 5 mg/1	TabletOral	Asclemed USA, Inc.	76420-763
Oxycodone hydrochloride	Oxycodone hydrochloride 15 mg/1	TabletOral	Asclemed USA, Inc.	76420-764